(130 days)
The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).
The KeyPort AR System is a reusable device used for creating and maintaining an artificial access port to body cavities including the necessary pneumoperitoneum. The KeyPort AR System allows multiple instruments and /or camera access during minimally invasive procedures, which include anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons. The KeyPort AR System is comprised of KeyPort silicone sealing insert (1), KeyPort AR trocar sleeve (2), and KeyPort trocar (3). The KeyPort AR System is used in conjunction with CO2 insufflator, Pump for smoke gas evacuation, and required instruments which are selected in accordance with the indications as well as the surgeon's requirements. Unless otherwise specified, all components of the KeyPort AR System are reusable and require sterilization before use. Methods of cleaning, disinfection, and sterilization are detailed in Instruction Manual GA-B 253-2 USA.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the KeyPort AR System:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization validation | All acceptance criteria were met. |
| Gas-tight seal | Verified acceptable results for a pressure up to 20mmHg. |
| Incision size (preclinical test) | An incision of 20mm is sufficient (using pigs). |
2. Sample size used for the test set and the data provenance:
- Sterilization validation: The sample size is not explicitly stated, but the results indicate that "All acceptance criteria were met."
- Gas-tight seal testing: The sample size is not explicitly stated.
- Preclinical test (incision size): The sample size is not explicitly stated, but it was conducted using "pigs."
- Data Provenance: The document does not specify the country of origin for the sterilization and gas-tight seal tests. The preclinical test used "pigs," implying an animal model study, which is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed (sterilization, gas-tight seal, preclinical incision size) do not typically involve human expert ground truth for their evaluation.
4. Adjudication method for the test set:
This information is not provided as the types of tests described do not involve adjudication by multiple experts in the same way clinical studies or image-based AI studies would.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. The device is a surgical access system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was done. The device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used:
- Sterilization validation: The ground truth would be established by specific performance standards for sterilization effectiveness (e.g., sterility assurance level), likely measured through microbiological assays.
- Gas-tight seal testing: The ground truth would be established by quantifiable pressure measurements and leakage rates against predefined thresholds.
- Preclinical test (incision size): The ground truth would be a direct observation of the surgical outcome (sufficiency of the incision) in the animal model.
8. The sample size for the training set:
Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for a physical medical device.
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AUG .3 2012
Revision 08-01-2012
120898
510(k) Summary
Page 1 of ③
| Submitter: | Date of Preparation: | |
|---|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | August 1, 2012 |
| Division name (if applicable): | N.A. | FDA establishment registration number: |
| Street address: | 353 Corporate Woods Parkway | 14 184 79 |
| City: | Vernon Hills | Phone number (include area code): |
| State/Province: | Illinois | ( 847 ) 913 1113 |
| Country: | USA | FAX number (include area code): |
| ZIP / Postal Code: | 60061 | ( 847 ) 913 0924 |
| Contact name: | Mr. Ron Haselhorst | |
| Contact title: | Quality Assurance / Regulatory Affairs Manager | |
| Parent Company: | ||
| Company / Institution name: | Richard Wolf GmbH | FDA establishment registration number: |
| Street address: | Pforzheimer Str. 32 | 96 111 02 |
| City: | Knittlingen | |
| State/Province: | Baden-Württemberg | |
| Country: | Germany | |
| ZIP / Postal Code: | 75438 | |
| Product Information: | ||
| Trade name: | KeyPort AR System | Model number: |
| 8850XX, 89XX | ||
| Common name: | Anoscope and accessories | Classification name: 876.1500, |
| Laparoscope & General Plastic Surgery | FER - Anoscope and accessories | |
| Laparoscope & Single Port Access Device | GCJ - Laparoscope & General Plastic Surgery | |
| OTJ - Laparoscope & Single Port Access Device | ||
| Information on devices to which substantial equivalence is claimed: | ||
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 K110792 | 1 Gelpoint Path (Product Code FER) | 1 Applied Medical Resources Corp |
| 2 K103253 | 2 Sils Port (Product Code GCJ, FER) | 2 Covidien (Formerly US Surgical) |
| 3 K000180 | 3 TEM Combination System and Instrument Set (Product Code FJL, GCM) | 3 Richard Wolf Medical Inst. Corp. |
| 4 K090275 (K014047) | 4 Gelport Single Incision Access System (Product Code GCJ) | 4 Applied Medical Resources Corp |
| 5 K110004 | 5 ASC Triport & Laparoscopic Access Device (Product Code OTJ, GCJ) | 5 Advanced Surgical Concepts. |
:
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Revision 08-01-2012
Device Description:
The KeyPort AR System is a reusable device used for creating and maintaining an artificial access port to body cavities including the necessary pneumoperitoneum. The KeyPort AR System allows multiple instruments and /or camera access during minimally invasive procedures, which include anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.
The KeyPort AR System is comprised of KeyPort silicone sealing insert (1), KeyPort AR trocar sleeve (2), and KeyPort trocar (3). The KeyPort AR System is used in conjunction with CO2 insufflator, Pump for smoke gas evacuation, and required instruments which are selected in accordance with the indications as well as the surgeon's requirements.
Unless otherwise specified, all components of the KeyPort AR System are reusable and require sterilization before use. Methods of cleaning, disinfection, and sterilization are detailed in Instruction Manual GA-B 253-2 USA.
Intended Use:
The KeyPort AR System access device is an endoscopic:accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).
Technological Characteristics:
The KeyPort AR System is technologically similar to devices found in this submission in that all/some of the devices:
- Have insufflation capability, ו
- Will maintain pneumoperitoneeum / pneumorectum, ।
- Have smoke evacuation capability,
- Have 3 ports that can seal against insufflation pressure as instruments are inserted. ー
- Have ports which are in a fixed position and are flexible in design, -
- Have ports that can accommodate laparoscopic instruments which vary in size from -5mm - 15mm,
- Is capable of being sutured to the patient to assist with retention, —
- Are made of materials which meet USP Class VI, ISO 10993-1 requirements and are latex free,
- Requires a trocar (introducer) for insertion into body cavity, |
- Are reusable and must be sterilized prior to each use.
The KeyPort AR System is technologically different to devices found in this submission in that:
- KeyPort trocar sleeve is rigid in design and is available with or without retention । threads.
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K12089.8
Page 3 of 3
Performance Data:
Sterilization validations were conducted for the Richard Wolf KeyPort AR System. All acceptance criteria were met.
Gas-tight seal testing verified acceptable results for a pressure up to 20mmHg, results from preclinical test using pigs show that an incision of 20mm is sufficient.
The submitted device is very similar to predicate devices found in this submission and the indications are well known. Therefore, no additional performance testing is necessary to demonstrate substantial equivalence.
Clinical Data:
No clinical tests performed.
Rational for Substantial Equivalence:
The Richard Wolf KeyPort AR System shares the same general indications for use, have similar function features and technological characteristics as the predicate devices, minor difference(s) do not raise new questions for safety or effectiveness. For these reasons, the Richard Wolf KeyPort AR System is substantially equivalent to the existing 510(k) cleared devices sold by: Applied Medical Resources Corporation (K110792, K090275), Covidien (K103253), Richard Wolf Medical Instruments Corporation (K000180), and Applied Medical Resources Corporation (K110004).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 3 2012
Richard Wolf Medical Instruments Corporation % Mr. Ron Haselhorst Quality Assurance, Regulatory Affairs Manager 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K120898
Trade/Device Name: KeyPort AR System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ Dated: June 21, 2011 Received: July 05, 2011
Dear Mr. Haselhorst:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Ron Haselhorst
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K120898
Device Name: KeyPort AR System
Intended Use:
The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).
Prescription use (Part 21 CFR 801 Subpart D)
and / or
Over-The Counter Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ANOTHER PAGE IF NEEDED
Concurrence of CDHR office of Device Evaluation (ODE)
miller dight
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1_
510(k) Number K120898
Section / Page 4-10 of 61
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.